K231398
- 510(k) number
- K231398
- Device name
- VUNO Med-DeepBrain
- Applicant
- Vuno, Inc. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2023-10-04
- Date received
- 2023-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231398.pdf
Official FDA record: K231398
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.